Purpose
Plan and execute all Production activities for delivering required quality and quantity of products
manufactured at Sanofi India limited by utilizing resources in optimum manner in order to ensure total
customer satisfaction with adherence to GMP/HSE standards
Resource And Time Management
Allocation of scheduled activity to Operators in the shift as per Production Plan. 2. Allocation of Manpower to associated activity in the shift wherever needed. 3. Allocation of necessary accessories to the operator/manpower as and when needed for completion of the activity. 4. Maintaining discipline amongst the manpower resources at all times and be a role model by strictly abiding the rules and regulation mentioned in certified standing orders. 5. Ensure to complete the scheduled activity (output) within standard time. 6. Prioritize activity to provide continuous feed to next process. (Ex. Dispensing to ensure feed for Granulation, Granulation to ensure feed to compression and Compression to ensure feed to coating/packing).
Shift handover and Vital communication
To communicate effectively with shift supervisors and sub-ordinates of the completed activity in the shift.
Share Vital Information regarding product critical to manufacturing during shift handovers through Status Board and Direct Communication.
Line Compliance and Adherence to Quality standards
Ensure that the activity executed by the Operator/Manpower is adhering to the effective SOP’s and is within the specified parameters/standard in BMR. Ensure that In-Process tests carried out for the process are as per the standard frequency mentioned in SOP and are complying within the acceptance criteria. 2. Identify, troubleshoot, report the Quality defects/ failure in process tests online if noticed and adhere to stringent AQL checks as specified in Batch Manufacturing Record and as per the procedure mentioned in the SOP. 3. Ensure to compile, check, and submit the completed batch manufacturing records to Quality assurance. 4. Ensure that the products are manufactured and stored as per the requirements, ensure implementation of the quality system, Good documentation practice for BMR, logbooks and Log cards, ensure that data integrity attributes are followed at all times.
SAP Management
Ensure creation of PO, Determination of Materials as per FIFO in SAP system. Ensure Goods Issue slip for completed batches in SAP. Carry out consumption for required tertiary packaging materials consumed in manufacturing of the product. Ensure that bulk posting of the completed batches in SAP is carried out as per requirement. Carry out Technically Complete (TECO) for finished process orders online.
Production planning and scheduling
Receive production plan from Manager-Production, plan, execute, interact with cross functional departments for communicating requirement for completion of plan.
Monitor daily activity, Plan changeovers in order to maximise activity in scheduled time for Dispensing, Granulation, Mixing and compression/coating.
Maintain adequate WIP levels and document for all products manufactured at Goa to achieve scheduled production with optimum resources.
Implement Process Excellence
Improve processes, cycle time, yields, optimum utilization of capacity in order to improve cost of goods manufactured. Devise Action plan in co-ordination with other team members to improve the process, quality and productivity. Update OEE and other equipment details in designated records from time to time and assist the Lean Management in gathering of required accurate data for process excellence.
Training and Development
Confirm that you are trained on relevant SOP’s before proceeding for execution of the activity.
Train and help subordinate to implement GMP/HSE systems and development of people.
Ensure all the new joiners are trained on the job before assigning them the job.
Train and help direct reports/sub-ordinates to implement GMP/HSE systems and development of people. Also training & guidance to subordinates for new product transfer strategy & documentation process (Validation protocol, BPR etc.).
Validation: Process, Re-Validation, product robustness
Co-ordinate in product re-validations, Process Validations, Study batches etc., make protocol and reports, validate manufacturing activity, and ensure release as per plan to successfully validate products at the Goa site. To Prepare Validation protocol for pilot scale batches, engineering batches and commercial scale batches as and when applicable. Execution and implementation of validation activity as per protocol. Preparation and approval of validation reports. Revision of MFR and BMR for inclusion of Post validation changes.
Adherence to Site HSE Systems
Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement. Initiate the departmental safety committee meeting. Take suggestion from associates to improve the work conditions with great safety and zero risk. Periodic review of the implemented procedures and evaluation of the same. Train people on safety and their job to ensure zero LTI and IWLT at workplace. Adherence to all health safety & environmental aspects as required by company policies and procedures. Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement. Conducting daily training in the +QDCI meeting address any unsafe condition.
Quality Compliance activities
Ensure completion and implementation of compliance activities in manufacturing i.e., deviation investigation, OOS and OOT investigation, CAPA implementation. Regulatory audit handling and CAPA implementation of the same. SOP revision for routine revision and Inclusion of corrective actions and preventive actions. Change Control management: Logging of change control and ensure to close the same after completion of activity in defined time. Revision of MFR, BMR: Revision for Inclusion/exclusion of material codes, Inclusion of Corrective actions/Preventive actions or any other changes required.
Qualification & Change Control
Assist in Qualification of any new Equipment/Modification: make URS, PQ protocol and reports. Ensure equipment qualification is as per GMP standards and User requirements along with supporting department.
Knowledge, Skills & Competencies / Language
Training management to direct reports and subordinates.
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